UK CLINICAL SUBMISSIONS
If you are thinking of launching a Clinical Investigation in the UK, watch our ‘How to’ Clinical Submissions Video Series:
Why do we need approvals?
Obtaining and maintaining approvals
No matter what classification of device, digital solution or IVD that you have, clinical strategy, clinical evidence and clinical evaluation are central to ensuring your product is safe and suitable for human use, for approval and access to global markets.
In order to effectively market your device and generate sales, you need to consider early in the development process the clinical elements and to efficiently implement the right integrated regulatory and clinical strategy.
To assist our clients Psephos provides the following clinical services:
- Integrated clinical and regulatory approach from first-in-human / early-stage Feasibility Studies through to pivotal trials
- Clinical trial strategy, design and management (ISO 14155 / MDR / FDA)
- UK Legal Representative, UK Responsible Person
- Competent Authority, Ethics Committee and related clinical study approvals
- Clinical Evaluation Plans and Reports
- Clinical Literature Search and Reviews
- Post- Market Surveillance (PMS)
- Post Market Clinical Follow-Up (PMCF), including registries
- FDA Q-Sub and related activities
- Clinical Safety DCB0160 and DCB0129
- Digital Technology Assessment Criteria (DTAC)